Avenue Therapeutics(US:ATXI)2024-08-09 20:13Clinical Trials - Avenue Therapeutics completed the last patient visit in the Phase 1b/2a clinical trial of AJ201 for spinal and bulbar muscular atrophy, with topline data expected in the second half of 2024 [2]. - The Phase 1b/2a trial enrolled 25 patients, with a primary endpoint focused on safety and tolerability of AJ201 at a dosage of 600 mg/day [3]. - The company plans to initiate a Phase 2a clinical trial of BAER-101 for focal epilepsy, pending additional financing [4]. - Avenue reached a final agreement with the FDA on the safety study protocol for the Phase 3 study of IV tramadol, which will involve approximately 300 patients [4]. Financial Performance - As of June 30, 2024, cash and cash equivalents totaled $4.9 million, an increase of $1.7 million from the previous quarter and $3.1 million year-to-date [6]. - Research and development expenses for Q2 2024 were $1.4 million, down from $3.0 million in Q2 2023 [6]. - General and administrative expenses for Q2 2024 were $1.5 million, compared to $0.9 million in Q2 2023 [6]. - The net loss attributable to common stockholders for Q2 2024 was $2.7 million, or $6.43 per share, compared to a net loss of $4.0 million, or $38.74 per share, in Q2 2023 [6]. - Avenue raised $4.4 million in gross proceeds from a warrant exercise transaction in May 2024 [5]. - Avenue's total stockholders' equity increased to $3.8 million as of June 30, 2024, compared to $654,000 at December 31, 2023 [11]. - Net loss for the three months ended June 30, 2024, was $2,701 million, compared to a net loss of $4,016 million for the same period in 2023, indicating an improvement of about 32.7% [13]. - Net loss attributable to common stockholders for the three months ended June 30, 2024, was $7,186 million, compared to $4,007 million for the same period in 2023, reflecting an increase of approximately 79.5% [13]. - Net loss per common share attributable to common stockholders for the three months ended June 30, 2024, was $6.43, compared to $38.74 for the same period in 2023, showing a significant decrease of about 83.4% [13]. - Total operating expenses for the six months ended June 30, 2024, were $3,752 million, down from $4,242 million for the same period in 2023, a reduction of approximately 11.5% [13]. - Loss from operations for the six months ended June 30, 2024, was $6,530 million, compared to $10,352 million for the same period in 2023, indicating an improvement of about 37.3% [13]. - Interest income for the three months ended June 30, 2024, was $52 million, slightly down from $57 million for the same period in 2023, a decrease of about 8.8% [13]. - Change in fair value of warrant liabilities resulted in a total other income (expense) of $255 million for the three months ended June 30, 2024, compared to $(150) million for the same period in 2023, reflecting a significant turnaround [13]. - Weighted average number of common shares outstanding for the three months ended June 30, 2024, was 1,117,769, compared to 103,442 for the same period in 2023, indicating a substantial increase in shares [13].